- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Francis J. Rossetti
- Banks Square Market Corp. dba The Produce Connection
96 Audubon Road
Wakefield, MA 01880
- Issuing Office:
- Office of Human and Animal Food Operations - East Division 1
CMS # 631118
Dear Mr. Rossetti:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) fresh-cut fruit and vegetable processing facility located at 96 Audubon Road Wakefield, MA 01880, from February 8, 2022, through March 21, 2022. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and the analytical results for the samples collected from your production environment, we have determined the RTE fresh-cut fruit and vegetable products processed in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov/.
At the conclusion of the inspection, the FDA investigators issued an FDA Form-483 (FDA-483), Inspectional Observations. You provided responses to the inspection and sample findings via email on April 11, May 11, and June 13, 2022, which included a summary of corrective actions you have taken and/or plan to take. After reviewing the inspectional findings and your responses to the observations listed in the FDA-483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not identify and implement preventive controls adequate to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 or § 343(w)], as required by 21 CFR § 117.135(a)(1).
Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Specifically, your facility receives fruit and vegetables, some of which are RTE, including cantaloupe and apples, that are processed into RTE sliced, diced, and/or cubed fruit and vegetable products (e.g., cubed cantaloupe and sliced apples). The RTE fruit and vegetable products are exposed to the environment prior to packaging, where they may become contaminated with environmental pathogens such as L. monocytogenes. Additionally, your RTE products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
Your hazard analysis for “Diced And Sliced Fruit,” dated January 12, 2022, identified pathogens including L. monocytogenes as a hazard requiring a preventive control for various processing steps such as "(b)(4)", "(b)(4)", and “(b)(4)”. Your hazard analysis further stated that “Good Manufacturing Practices/ Sanitation Program/ Training” are the measures taken to apply your sanitation preventive control of “Post wash - Documented sanitation procedure to ensure food contact surfaces post treatment for RTE product”. However, as described below, this preventive control did not ensure the facility was maintained in a sanitary condition adequate to significantly minimize or prevent the hazard of recontamination with environmental pathogens. In establishing sanitation preventive controls, you should consider all potential sources of facility-related biological hazards, including employee handling and environmental pathogens associated with your manufacturing within a wet processing environment (which increases the potential for environmental pathogens to be present and spread within the facility). As evidenced by the findings of L. monocytogenes in your production environment and current inspectional findings, you did not identify and implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR § 117.135(a)(1) and (c)(3).
FDA laboratory analysis of the environmental sample 1119291 collected on February 8, 2022, from various areas in your processing facility confirmed eight (8) of fifty-six (56) environmental swabs were positive for L. monocytogenes. Of the positive findings, three (3) swabs were collected from food-contact surfaces where RTE cantaloupe and RTE sliced apples were being prepared, including:
- Surface of the stainless-steel fruit table used for coring apples
- Blade of the yellow knife used to cut cantaloupe
- Green squeegee used for wiping the surface of the stainless-steel table where cantaloupes were being processed
In addition, L. monocytogenes was found on a tote used for holding bulk/whole cantaloupe.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental sample. The WGS analysis determined that the eight (8) environmental isolates represented three (3) strains of L. monocytogenes. Most notably, two of these strains are genetically identical to clinical isolates, which indicates theses strains have the capability of causing human illness. The first of these strains was identified in two environmental isolates collected from your firm and is a match to a clinical isolate from 2019 and a match to three (3) other environmental isolates from other sources. The second strain was identified in one environmental isolate and matches a clinical isolate from 2019. Additionally, a third strain identified in five (5) environmental isolates matches a 2021 environmental isolate from Florida, but no clinical isolate. We advised you of these WGS results via a conference call on March 14, 2022.
In addition to finding L. monocytogenes in your plant, during the current inspection FDA detected non-pathogenic Listeria species (Listeria spp.), in environmental samples collected from your firm. FDA laboratory analysis of the environmental sample 1119291 collected on February 8, 2022 confirmed two (2) swabs positive for Listeria spp. These swabs were collected from the surface of a floor mat on the side of a fruit cart (Sub #15) and the underside of a shelf on a cart used to hold sliced apples (Sub #23). The presence of non-pathogenic species of Listeria indicates that conditions are suitable for survival and/or growth of L. monocytogenes in the locations where they are found.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
Furthermore, during the current inspection, investigators observed employee handling practices which could lead to cross-contamination of food-contact surfaces and RTE food products. We also note that we previously informed you of our concerns related to cross-contamination during a 2019 inspection of your facility. Specifically, during the current inspection, we observed the following:
- On February 8, 2022, employees peeled, sliced, and packaged apples in lot # (b)(4), and then handled chipped and broken food waste containers and garbage cans, without changing their gloves or washing and sanitizing their hands prior to returning to (b)(4) processing RTE apples. FDA environmental swab (Sub #17) was collected from the outside rim and chipped surface area of the green 50-gallon plastic barrel being used to discard apple cores in the fruit processing area during this time period and found positive for L. monocytogenes.
- On February 8, 2022, employees peeled, sliced, and packaged RTE cubed cantaloupe in lot # (b)(4), and then handled food waste containers, garbage cans, and plastic totes, without changing their gloves or washing and sanitizing their hands prior to returning to processing RTE cantaloupe. FDA environmental swab (Sub #35) was collected from the exterior surface of the tote used for holding the bulk/whole cantaloupe during processing and found positive for L. monocytogenes.
- On February 8, 2022, employees used a green squeegee to wipe food-contact surfaces of a table after processing RTE cantaloupe and then immediately processed pineapple on the same table. FDA environmental swab (Sub #30) was collected from the green squeegee during processing and found positive for L. monocytogenes.
On February 28, 2022, after FDA reported the positive L. monocytogenes environmental sample results, you stated that you ceased fruit production that did not have “(b)(4)” and began your root cause investigation. During that time, you also stated that cantaloupe lot # (b)(4) and apples lot # (b)(4) had expired, as your RTE cut fruit products have a shelf life of 7-10 days. You also reported that your firm conducted cleaning and sanitizing of processing tables and equipment beyond your normal sanitation procedures; reswabbed the positive environmental sample locations; and began identifying and implementing corrective actions in response to the environmental sample findings.
Your April 11, 2022 response further stated that you retained third-party consultants to assist with review of your internal programs and procedures, with a specific focus on sanitation, environmental monitoring, and root cause analyses. Your response included information regarding your conclusion that the root peeler, which peels root vegetables such as turnips, was the potential source of the contamination and that you removed the peeler from production. You also identified sanitation failures (including employee cleaning practices) as the likely cause of cross-contamination to other equipment and areas in your facility. You stated that you disposed of the plastic barrel used to discard apple cores, disposed of and replaced all squeegees used in the facility and developed a new cleaning and storage procedure for squeegees on which your employees were trained, installed a new sink and three soap/sanitizer stations in the production area, and cleaned, sanitized, and relocated the stainless-steel fruit production tables.
Furthermore, in your subsequent May 11, 2022 response you stated that the root peeler (the potential source of contamination) remains out of production, and, in the event that you bring the root peeler back into production, you will work with experts on how to break down, potentially modify, clean, and sanitize it to help ensure it does not pose a risk of cross-contamination. You also stated that a color-coding system has been implemented for equipment and clothing used in production, such that employees wearing certain colored sleeves can only handle designated types of equipment and materials, to help prevent cross-contamination. You also indicated that these changes have been included in your revised sanitation procedures. You also conducted handwashing and glove usage training and developed a new (b)(4) GMP checklist. In addition, this response included revised cleaning and sanitation procedures, documentation of employee training on the new procedures, and revised environmental monitoring procedures.
Your follow up response on June 13, 2022 included additional updates on your corrective action response, including (b)(4) to your environmental monitoring program, and further updates to your sanitation audit program. Lastly, you stated that you have not detected any positives in the facility since May 3, 2022.
Although your root cause investigation and subsequent corrective actions suggest you have identified and corrected the source of the contamination found in the facility, we encourage you to continue to evaluate your facility to ensure you have identified all areas where L. monocytogenes is likely to be found. You should also continue to implement the necessary methods and controls to ensure foodborne pathogens do not contaminate your RTE food products. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically, FDA investigators observed the following:
- On February 10, 2022, an employee used a high-pressure hose that had contacted the floor before use and sprayed the rear wall of the main production facility during production of RTE romaine lettuce. The spray from the hose was observed contacting the floor several times and creating an aerosol and mist within the production area that was also visible in the air several feet away from the RTE romaine that was processed. Note that high-pressure hoses create overspray and aerosols that can transfer and spread pathogens from the environment to food contact surfaces, and floors are common sources of environmental pathogens such as L. monocytogenes. We have previously notified you of our concerns related to cross-contamination from high-pressure hose usage during FDA inspections in 2018 and 2019.
- On February 22, 2022, an employee used a high-pressure hose to clean a large spinner machine during manufacturing of RTE diced onions in the main production room, then contacted the floor with the hose, causing spray water to aerosolize and splash directly from the floor onto draining bins located approximately five feet away that contained RTE diced onions. We note that when you were informed of this observation by the FDA investigator during the inspection, you disposed of 200 pounds of diced onions.
Your April 11, 2022 response stated that you eliminated the use of eight high-pressure hoses and refit the remaining hoses with new heads which you state do not allow for high pressure during use. We will verify the effectiveness of your corrective actions during our next inspection.
2. You did not maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, FDA investigators observed the following:
- On February 8, 2022, condensate was observed dripping from the overhead ceiling and refrigeration unit in the main production room to the floor, approximately 10 feet from where RTE diced red onion was being processed. We have previously notified you of our concerns related to condensate during FDA inspections conducted in 2018 and 2019.
- On February 10, 2022, the plastic conveyer belt that you use for production of your butternut squash product was damaged, with rough surfaces and missing teeth.
- On February 22, 2022, several areas of flooring and surfaces around drains in the main production area were damaged, with exposed rough aggregate.
- On February 22, 2022, plastic bins/barrels used to hold RTE finished products, vegetable and fruit waste, and garbage were damaged, cracked, and chipped, with rough surfaces.
Your April 11, 2022 response stated you replaced all cracked/broken barrels, repaired the damaged floors, and purchased new (b)(4) for the (b)(4) in the production area. Your May 11, 2022 response stated that you revised your condensation procedures to include ensuring the HVAC units that present the most risk will be monitored and cleaned of condensation (b)(4). You also stated that you installed dehumidifiers in certain production areas to help reduce humidity and condensation. Furthermore, your follow up response dated June 13, 2022 indicated that you are installing refrigeration units in the areas adjacent to the main production room, which will help maintain a more consistent temperature in the facility and thereby decrease condensation.
We will verify the effectiveness of your corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their reoccurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations noted in this letter. Failure to do so may result in legal action, including, without limitation, seizure, injunction, administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comment:
- Your hazard analysis for “Diced And Sliced Fruit” dated January 12, 2022 identified biological hazards, such as L. monocytogenes and Salmonella, as hazards requiring a preventive control at your “(b)(4)” step, but stated this hazard did not require a preventive control because “(b)(4).” Additionally, your hazard analysis identified biological hazards at your “(b)(4)” step, but indicated that there are no food safety hazards requiring a preventive control at this step because “(b)(4).” We note that pathogens such as Salmonella, L. monocytogenes, and pathogenic E. coli are known or reasonably foreseeable hazards in raw agricultural commodities such as fruits and vegetables and have resulted in foodborne illnesses, some of which are severe. As noted above, your “(b)(4)” step stated that biological hazards, such as pathogens, would be controlled by a process preventive control (PPC (b)(4)) at step “(b)(4)” prior to cutting. (b)(4) is used in your wash dip tank and the label directions for use state that it “may be used as an antimicrobial agent for use in process water used for washing or chilling fruits and vegetables” and when used as directed “reduces bacterial contamination and cross-contamination that may cause product spoilage or decay of edible food products such as fruits and vegetables in food processing facilities.” However, this solution does not significantly minimize or prevent pathogens that may require a preventive control at other stages of production, such as pathogens on incoming produce or in the production environment. Biological hazards at receiving that require a supply-chain applied control (i.e., you are not controlling the hazard) should be controlled by your supply chain program, which includes supplier approval and supplier verification activities, such as onsite audits, to ensure that the incoming whole fresh fruit from your suppliers has minimal risk of contamination with pathogens at receipt.
Please notify FDA in writing within 15 working days of the receipt of this letter of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the reoccurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: Scott Izyk, Compliance Officer, One Winner’s Circle, Suite 140, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Izyk at 518-453-2314 x1012 or email@example.com.
Program Division Director
Office of Human and Animal Food Operations -
East Division 1